FDA has approved Wynzora® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) from MC2 Therapeutics for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older.
The approval is based on results of the US Phase 3 clinical trial against active comparator Taclonex® Topical Suspension (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%). The randomized trial involved 794 patients. At week 8, there was a 14.6% difference in the primary efficacy endpoint—the proportion of patients with PGA treatment success at week 8 defined as at least a 2-grade improvement from baseline in PGA to “clear” or “almost clear”—for Wynzora Cream, versus active comparator.
A higher proportion of patients achieved at least a 4-point improvement in the peak pruritus NRS score at week 4 in the Wynzora Cream group compared to vehicle.
Wynzora® Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. Wynzora Cream is based on PAD Technology, which uniquely enables stability of both active ingredients in an aqueous formulation.
“Wynzora® Cream is a novel topical treatment for plaque psoriasis which offers a unique combination of high efficacy, favorable safety and excellent treatment convenience in a single product,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, and lead principal investigator in the study.